Administrative Core

Among its many responsibilities, the ADCS Administrative Core provides administrative, fiscal, and regulatory support for the organization as a whole. In addition, the Administrative Core, through its Minority Recruitment Core, oversees study participant recruitment and retention.

The Administrative Core liaises with Steering Committee members, the External Advisory Board (EAB), as well as other external and internal stakeholders. The Administrative Core coordinates and executes all ADCS Steering Committee and related subcommittee meetings.

The Administrative Core also makes decisions involving coordinating center policies, prioritizing workflows, and allocating resources and personnel. Likewise, it oversees the development of ADCS standard operating procedures (SOPs). Furthermore, the Administrative Core is essential to the function of the ADCS as a cohesive unit and ensures the entire cooperative study operates efficiently.

Finance

The Finance Unit of the Administrative Core provides fiscal control for the operations of the ADCS, generates payments to participating research sites for work completed, establishes and maintains contracts with vendors and research sites, and manages all aspects of ADCS grant proposal submissions.

Recruitment and Retention

The Recruitment and Communications Unit maximizes efficient enrollment of participants and subsequent successful retention. The recruitment coordinators use many well-thought-out techniques including newsletters, web-based communication, direct mail, press releases, and placement of all studies on both public and private clinical study websites.

They also provide training to participating sites on recruitment, retention, public relations, and making use of local media. Tools are provided for sites, including reference cards, bookmarks, flyers, brochures, protocol-specific information sheets, videos and DVDs, and newsletters.

The team monitors enrollment at each site and offers assistance for identifying recruitment barriers and potential target audiences.

Regulatory Affairs

The Regulatory Affairs (RA) Unit manages the regulatory complexities of ADCS clinical trials. The RA Unit assists with protocol development and works with Project Directors to ensure the protocol meets all regulatory requirements, including those for informed consent, HIPAA, and NIH data-sharing requirements.

The Unit creates, reviews, and assesses research material submitted to regulatory agencies, affiliated institutions, and their Institutional Review Boards (IRB). Regulatory files are maintained at the Coordinating Center and include current IRB approvals and other essential documents for each project in which a research site participates.

Ongoing communication with the IRB, sponsors, FDA, and other regulatory agencies allows the RA Unit to ensure submission and follow-up of appropriate documentation at the local level.

The Unit has designed a thorough protocol initiation process and collaborates with study sites so the RA can release study drug and approve sites for subject enrollment. The RA Unit also oversees and collects Conflict of Interest reports for all members of the ADCS.

Information Technology and Software Development

The Information Technology and Software Development Unit develops technology solutions and manages computing infrastructure, network connectivity, and security for ADCS.

Staff researches and develops software systems for the ADCS, including the ADCS public website, administrative website, contact management system, site payments system, requisition management system, and asset tracking system.

It also provides technical services and support to the Administrative Core, Medical Core, Clinical Operations, and the ADCS Biomarker Lab.

Biorepository Core

The Biorepository Core provides laboratory support for all ADCS clinical trials. The Core consists of a wet laboratory and a biospecimen bank. The Core processes and banks blood, DNA, plasma/serum, and CSF samples from patients who participate in ADCS trials.

In addition, the Biorepository Core is responsible for ApoE genotyping analyses, drug PK, and compliance.

The Biorepository Core works closely with the Clinical Operations Core to assemble supply lists, develop procedure manuals, and assist with protocols for ADCS clinical trials.

The goal of the Biorepository Core is to use bioassays to provide endpoint biomarker data on the impact of the treatment regime in clinical trials and to identify novel biomarkers for Alzheimer's disease from a research perspective.

Biostatistics Core

The Biostatistics Core provides biostatistical expertise for the design, management, and analysis of the Alzheimer's Disease Cooperative Study (ADCS) clinical investigation and generates randomization sequences for treatment allocation for all ADCS randomized controlled trials.

The Biostatistics Core is charged with the following responsibilities:

  • Study Design
  • Development
  • Implementation
  • Study Analysis and Closeout
  • External Collaborations

Clinical Operations

The Clinical Operations Core has directed the initiation, implementation, day-to-day activities, and close-out for 23 completed or ongoing multicenter clinical studies, as well as seven multicenter protocols to develop novel instruments for use in Alzheimer's disease clinical studies.

This group provides ongoing daily support to study centers, including designing and providing graphic study materials, participant and study site newsletters, and other documents.

The number of centers participating in each protocol has ranged from 9 to 80, with the majority of protocols consisting of 20 or more participating centers.

Imaging Core

The Imaging Core serves the imaging needs of ADCS clinical trials, including imaging protocol design, site setup, imaging data quality control and management, and quantitative analysis for secondary outcome measures.

The Imaging Core provides the following services:

  • Magnetic Resonance Imaging (MRI)
  • Positron Emission Tomography (PET)

For all studies, data are managed, organized, and curated to assure a format that facilitates wide sharing of these valuable data once the study is complete, including robust procedures to confirm that these complex data objects are free of patient-identifying information.

At study closeout, the Imaging Core works closely with other cores to procure high-quality and optimally curated imaging data analyzed with state-of-the-art approaches.

Informatics & Data Management Core

The Informatics & Data Management Core provides computer analysis tools for the ADCS and assists with the daily operations of all ADCS clinical studies.

Informatics

The Informatics group provides computer programming and analysis for the ADCS. The group is committed to providing ADCS with secure, high-quality, cutting-edge web-based data management services and applications.

Research services include:

  • Online Clinical Trial Portals
  • Electronic Data Capture
  • Quality Assurance Toolkits
  • Data Mining
  • Online Reporting
  • Distributed Document Repository

With a rich pipeline of new services and applications, this Core is well positioned to continue delivering innovative data management solutions to the ADCS.

Its solutions are designed to enhance:

  • Data Capture
  • Data Integrity and Validity
  • Regulatory Compliance
  • Efficient Completion of Research Objectives

Staff have extensive experience providing informatics services to facilitate multi-site randomized clinical trials and observational studies.

Data Management

The ADCS Data Management group is responsible for the day-to-day operations of all ADCS clinical studies from inception to final data analysis.

The Data Management group is comprised of:

  • Data Entry
  • Quality Control
  • Data Systems
  • Biostatistics

Data entry, reporting, subject approval, randomization, quality control, analysis, and study tracking are implemented using an automated web-based system connected to a central database.

Project Directors and ADCS Coordinating Center staff have remote online access to a private intranet customized for each protocol.

The Data Management group supports each protocol through protocol development and finalization, training meetings, case report form generation, ongoing training of new site staff, data collection, quality control, and study tracking.

Online reports are continually available to track study enrollment and ongoing study visits across sites. Electronic forms include real-time data checking algorithms to provide immediate quality feedback.

Medical Safety Core

The Medical Safety Core (MSC) provides medical oversight of trial activities through a comprehensive system of medical and safety monitoring for all ADCS studies.

Medical Operations

Medical Operations provides immediate, independent Safety Physician review of all serious adverse events (SAEs), as well as clinical oversight to ensure patient safety by systematically processing, coding, and reviewing study-related safety data.

Clinical Monitoring

The Clinical Monitoring aspect of the MSC provides off-site review of electronic case report forms, on-site monitoring of study procedural compliance and data in all ADCS clinical trials, and training and certification for ADCS monitors.

Minority Recruitment Core

The specific aims of the Minority Recruitment Core are to maximize participation of minorities in all aspects of ADCS research efforts and to ensure that their interests are represented in the research agenda.

The Minority Recruitment Core provides a full range of recruitment and retention activities to increase minority participation, reviews protocols with Project Directors to reduce barriers to minority recruitment, evaluates sites for selection with regard to maximizing minority recruitment, supports and trains staff in recruitment and retention activities, and evaluates ADCS activities to ensure compliance and effectiveness in minority recruitment.